The present invention relates to a pessary for treating prolapse of a vagina, and more particularly to such a pessary having a variable longitudinal dimension.
Intravaginal pessaries are support devices intended to reduce pelvic organ prolapse (e.g., cervical, uterine, vaginal, bladder and/or rectal prolapse). They are varied in type and size and are typically fitted according to the individual patient's anatomy. One of the problems encountered by the majority of pessary users over time is the development of intravaginal ulcers due to pressure necrosis.
An optimum vaginal support device should supplant torn or broken endopelvic facia or weak vaginal muscle with maximum support in the area of the specific individualized pelvic floor defect (whether muscular weakness or facial tear) without undue pressure on the delicate vaginal mucosa. An optimum pessary must adapt to the fact that most introituses are smaller than the vaginal cavity which they are meant to occupy in order to support the pelvic floor defects, yet the pessary must be large enough to correct all pelvic floor defects and small enough and delicate enough to fit even the smallest introitus (i.e., vaginal opening) and cause the least amount of pelvic floor problems such as infection or ulceration. A three dimensional pessary is preferred in order that the pessary used for an individual pelvic type may be stretched after insertion to fill the area where the specific pelvic floor defects exist (such as inferiorly toward the lateral vaginal wall support, medially toward the cervix or upper vaginal vault, posteriorly to correct rectocele or laterally, to correct a lower lateral vaginal wall support defect). The object of the pessary is to restore the patient's original anatomy with a minimum of obstruction and pressure on the delicate surrounding tissues, and thereby requires an optimum fit to obtain maximum comfort.
U.S. Pat. No. 4,823,814 discloses a pessary particularly applicable in the treatment of prolapses of internal female sex organs such as the vagina. The pessary is formed by a ring-shaped member constructed of materials which can be deformed by hand to any given shape and the circumferential dimension of the ring can be increased or decreased to some extent by hand, after which the ring retains the ultimately given shape and circumferential dimension. Preferably the ring consists of a core which has the shape of a spiral of non-resilient nature and a flexible casing enclosing the core. While the patented pessary is today in common use, it has not proven to be entirely satisfactory.
Ideally, the pessary will have a three dimensional configuration so that it can be used for the treatment of several defects at once. One defect of the aforementioned pessary disclosed in U.S. Pat. No. 4,823,814 is that the ring structure is essentially planar, rather than three dimensional, and thus cannot be used to treat several prolapses at the same time. A further defect is that the exertion of pressure on the pessary--whether a manual pressure as used to insert it through the introitus into the vaginal cavity or the pressure exerted on the pessary by the vaginal walls after insertion (as opposed to during insertion)--may deform the pessary from its contemplated configuration so that it is no longer capable of performing its intended function.
Accordingly, it is an object of the present invention to provide an intravaginal pessary for treating prolapses wherein the longitudinal length of the pessary intermediate two portions thereof may be fixed within limits.
Another object is to provide such a pessary wherein the longitudinal dimension may be locked or fixed within limits.
A further object is to provide such a pessary wherein the longitudinal dimension may be unlocked or unfixed so as to enable modification thereof.